NDC 10122-212

Bronchitol

Mannitol

Bronchitol is a Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Mannitol.

Product ID10122-212_159b4a7c-bc10-493f-9ead-e0b7f9563eef
NDC10122-212
Product TypeHuman Prescription Drug
Proprietary NameBronchitol
Generic NameMannitol
Dosage FormCapsule
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-02-01
Marketing CategoryNDA / NDA
Application NumberNDA202049
Labeler NameChiesi USA, Inc.
Substance NameMANNITOL
Active Ingredient Strength40 mg/1
Pharm ClassesIncreased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10122-212-02

1 BLISTER PACK in 1 CARTON (10122-212-02) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01)
Marketing Start Date2021-02-01
NDC Exclude FlagN
Sample Package?Y

Drug Details

NDC Crossover Matching brand name "Bronchitol" or generic name "Mannitol"

NDCBrand NameGeneric Name
10122-212Bronchitolmannitol
67850-552Aridol Bronchial Challenge Test Kitmannitol
62171-100GD11 Rx SCM C5MANNITOL
0264-2303MannitolMannitol
0264-7578MannitolMANNITOL
0404-9905MannitolMannitol
0409-4031MannitolMANNITOL
0409-7715MannitolMANNITOL
0990-7715MannitolMANNITOL
51662-1468MANNITOLMANNITOL
52584-031MannitolMannitol
63323-024MannitolMANNITOL
0338-0351OsmitrolMannitol
0338-0353OsmitrolMannitol
0338-0355OsmitrolMannitol
0338-0357OsmitrolMannitol

Trademark Results [Bronchitol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BRONCHITOL
BRONCHITOL
79012340 3107109 Live/Registered
Pharmaxis Ltd
2005-06-01

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